The Consumers Association of Penang is appalled at the deafening silence by the Ministry of Health and GlaxoSmithKline Malaysia (GSK) over the widespread contamination of Rotarix, GSKs oral vaccine given to infants less than 12 months of age to prevent rotavirus that can cause gastroenteritis leading to vomiting, diarrhea and fever. Batches of Rotarix all over the world have been contaminated with genetic material from porcine circovirus type 1 (PCV1) – a virus commonly found in pigs.
Rotavirus is a genus of double-stranded RNA virus in the family Reoviridae. It is the leading single cause of severe diarrhoea among infants and young children, and is one of several viruses that cause Rotavirus gastroenteritis, a mild to severe disease characterised by vomiting, watery diarrhoea, and low-grade fever and commonly known as stomach flu, despite having no relation to influenza. By the age of five, nearly every child in the world has been infected with rotavirus at least once. However, with each infection, immunity develops and subsequent infections are less severe, and adults are rarely affected. There are seven species of this virus, referred to as A, B, C, D, E, F and G, all of which also cause disease in other animals. Rotavirus A, the most common, causes more than 90% of infections in humans.
A rotavirus vaccine such as GSKs Rotarix is supposed to protect children from rotaviruses. A media report described Rotarix as being made from a weakened strain of human rotavirus that has to be grown inside living cells. GSK uses a line of monkey kidney cells for this purpose. According to Dr Margaret Hamburg, commissioner of the US Food and Drug Administration (FDA), PCV1 DNA fragments were found in Glaxo's cell bank, meaning they were present from the vaccine's earliest development when in fact, vaccines are supposed to be sterile. It is highly unlikely that GSK was not aware of this anomaly in their vaccine long before 2006 when they carried out clinical trials on Rotarix in children. We question why GSK has not made any effort to isolate and destroy the rogue virus PCV1 in the initial reassortment of genetic material required to produce the vaccine when it would have been clearly visible to scientists if safety was a priority. It is shocking that GSK has allowed this potentially dangerous abnormality to continue to perpetuate itself over the years until it has emerged as a contaminant for a vaccine meant for infants as young as six weeks old. In fact, GSK only reported its own findings of the presence of PCV1 in Rotarix to the FDA on March 15, based on work originally performed by an academic research team. Subsequent follow-up tests carried out jointly by GSK and the FDA confirmed the team’s findings and confirmed that viral components have been present since the early stages of the vaccine’s development, including during clinical studies.
While claiming that there is no evidence that there is a risk to patients who have received this vaccine, the FDA however had on March 22 decided to err on the side of caution and issued a nationwide alert warning pediatricians in the US to stop administering Rotarix to their patients pending an investigation that is expected to last at least six weeks. The FDA also publicly admits that until now this particular pig virus is not one that they thought vaccine makers needed to check their products against.
As of 27 March 2010, the Health Ministry of the United Arab Emirates has taken cue from the FDA and has ordered the immediate suspension of importation, distribution and selling of Rotarix and a temporary ban on its use on infants. Jordan through its Food and Drugs Administration has also adopted the FDAs position by suspending all Rotarix prescriptions as they fear the risk of unknown side effects from PCV1. Closer to home, Singapore’s Health Sciences Authority (HSA) are asking doctors to defer vaccination by Rotarix or use alternatives while the HSA works with GSK to determine if any local batches of the Rotarix vaccine had been contaminated. In a statement, the World Health organization (WHO) urged countries using Rotarix to "carefully consider the significant benefits of continued use" in any decisions.
While GSK Malaysia and Singapore 's director of clinical R&D and medical affairs, Dr Teoh Yee Leong, said the drugmaker assured the HSA that they would "continue to share information with HSA as and when these become available", the same level of cooperation does not seem to have been extended to our Ministry of Health. Going by the absolute silence of the Drug Control Authority (DCA) of the MOH on this matter, it would seem that GSK has for some reason refused to divulge any information on this critical issue to the MOH despite it being 12 days since they reported the matter to the US FDA. While being very cooperative with the HSA of Singapore, GSK Malaysia seems to have completely avoided all similar collaboration with MOH despite the MOH openly recommending the use of Rotarix in Malaysia. We wonder if this is really the case or are the rakyat deliberately being kept in the dark.
In a Muslim majority nation like ours, it is understandable that such an issue can be a sensitive one, especially since the vaccine’s contaminant is from a virus of pork origin. As we all know, the consumption of pork is ‘haram’ or forbidden to Muslim’s. One scientific rationale as to why pork is categorized so by Islam is due to the presence of parasitic creatures such as the Taenia solium (pork tapeworm) and Trichinella spiralis (trichina worm) and microorganisms such as porcine circovirus type 1 which are undoubtedly harmful to human health. This is why PCV1 contaminated Rotarix is unacceptable to Muslims but the MOH has a responsibility not only to Muslims but rakyat of all other religions in the country to explain the situation as well as initiate urgent measures to recall and analyse the existing batches of Rotarix for contamination while announcing a nationwide alert and suspension of the vaccine until safety has been substantiated.
The governments of UAE and Jordan where Islam is the predominant and official religion have been exemplary in their immediate and proactive reactions towards the threat of contaminated Rotarix. They have shown a great deal of concern and responsibility to their citizens due to the nature of the threat which is both health endangering as well as having religious relevance and they have announced their decisions publicly.
Whether or not GSK Malaysia has alerted the MOH, we question why the MOH has yet to declare a nationwide alert and suspension of Rotarix vaccinations as of today and carry out stringent safety testing on existing batches. What has the MOH done to inform and assure the rakyat of their children’s safety? Just what is stopping the MOH from carrying out its duties and responsibilities to the rakyat? The rakyat have a right to know if their health and religious beliefs may be compromised.
A rotavirus vaccine such as GSKs Rotarix is supposed to protect children from rotaviruses. A media report described Rotarix as being made from a weakened strain of human rotavirus that has to be grown inside living cells. GSK uses a line of monkey kidney cells for this purpose. According to Dr Margaret Hamburg, commissioner of the US Food and Drug Administration (FDA), PCV1 DNA fragments were found in Glaxo's cell bank, meaning they were present from the vaccine's earliest development when in fact, vaccines are supposed to be sterile. It is highly unlikely that GSK was not aware of this anomaly in their vaccine long before 2006 when they carried out clinical trials on Rotarix in children. We question why GSK has not made any effort to isolate and destroy the rogue virus PCV1 in the initial reassortment of genetic material required to produce the vaccine when it would have been clearly visible to scientists if safety was a priority. It is shocking that GSK has allowed this potentially dangerous abnormality to continue to perpetuate itself over the years until it has emerged as a contaminant for a vaccine meant for infants as young as six weeks old. In fact, GSK only reported its own findings of the presence of PCV1 in Rotarix to the FDA on March 15, based on work originally performed by an academic research team. Subsequent follow-up tests carried out jointly by GSK and the FDA confirmed the team’s findings and confirmed that viral components have been present since the early stages of the vaccine’s development, including during clinical studies.
While claiming that there is no evidence that there is a risk to patients who have received this vaccine, the FDA however had on March 22 decided to err on the side of caution and issued a nationwide alert warning pediatricians in the US to stop administering Rotarix to their patients pending an investigation that is expected to last at least six weeks. The FDA also publicly admits that until now this particular pig virus is not one that they thought vaccine makers needed to check their products against.
As of 27 March 2010, the Health Ministry of the United Arab Emirates has taken cue from the FDA and has ordered the immediate suspension of importation, distribution and selling of Rotarix and a temporary ban on its use on infants. Jordan through its Food and Drugs Administration has also adopted the FDAs position by suspending all Rotarix prescriptions as they fear the risk of unknown side effects from PCV1. Closer to home, Singapore’s Health Sciences Authority (HSA) are asking doctors to defer vaccination by Rotarix or use alternatives while the HSA works with GSK to determine if any local batches of the Rotarix vaccine had been contaminated. In a statement, the World Health organization (WHO) urged countries using Rotarix to "carefully consider the significant benefits of continued use" in any decisions.
While GSK Malaysia and Singapore 's director of clinical R&D and medical affairs, Dr Teoh Yee Leong, said the drugmaker assured the HSA that they would "continue to share information with HSA as and when these become available", the same level of cooperation does not seem to have been extended to our Ministry of Health. Going by the absolute silence of the Drug Control Authority (DCA) of the MOH on this matter, it would seem that GSK has for some reason refused to divulge any information on this critical issue to the MOH despite it being 12 days since they reported the matter to the US FDA. While being very cooperative with the HSA of Singapore, GSK Malaysia seems to have completely avoided all similar collaboration with MOH despite the MOH openly recommending the use of Rotarix in Malaysia. We wonder if this is really the case or are the rakyat deliberately being kept in the dark.
In a Muslim majority nation like ours, it is understandable that such an issue can be a sensitive one, especially since the vaccine’s contaminant is from a virus of pork origin. As we all know, the consumption of pork is ‘haram’ or forbidden to Muslim’s. One scientific rationale as to why pork is categorized so by Islam is due to the presence of parasitic creatures such as the Taenia solium (pork tapeworm) and Trichinella spiralis (trichina worm) and microorganisms such as porcine circovirus type 1 which are undoubtedly harmful to human health. This is why PCV1 contaminated Rotarix is unacceptable to Muslims but the MOH has a responsibility not only to Muslims but rakyat of all other religions in the country to explain the situation as well as initiate urgent measures to recall and analyse the existing batches of Rotarix for contamination while announcing a nationwide alert and suspension of the vaccine until safety has been substantiated.
The governments of UAE and Jordan where Islam is the predominant and official religion have been exemplary in their immediate and proactive reactions towards the threat of contaminated Rotarix. They have shown a great deal of concern and responsibility to their citizens due to the nature of the threat which is both health endangering as well as having religious relevance and they have announced their decisions publicly.
Whether or not GSK Malaysia has alerted the MOH, we question why the MOH has yet to declare a nationwide alert and suspension of Rotarix vaccinations as of today and carry out stringent safety testing on existing batches. What has the MOH done to inform and assure the rakyat of their children’s safety? Just what is stopping the MOH from carrying out its duties and responsibilities to the rakyat? The rakyat have a right to know if their health and religious beliefs may be compromised.
CAP calls upon the MOH to immediately inform the rakyat of the Rotarix contamination situation in the country and the steps to taken to contain the situation.
Letter to the Editor - 26 March 2010
Sumber: http://www.consumer.org.my
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